What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as fluorouracil and oxaliplatin, are associated with several side effects. Fluorouracil can cause diarrhea, nausea, vomiting, stomatitis, and fatigue. Oxaliplatin is known for causing neuropathy, which can persist long after treatment. Targeted therapies, like those being studied in the M9140 trial, often have different toxicity profiles, including skin reactions, hypomagnesemia, and infusion-related reactions. Overall, the side effects can vary but often include gastrointestinal disturbances, fatigue, and neuropathy.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of advanced colorectal cancer. Notable among these are monoclonal antibodies like cetuximab and panitumumab, which target the epidermal growth factor receptor (EGFR). Additionally, bevacizumab, an anti-VEGF antibody, has been approved to inhibit angiogenesis. More recently, immune checkpoint inhibitors such as pembrolizumab and nivolumab, which target PD-1, have been approved for microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancers. These therapies represent significant advancements in the treatment of advanced solid tumors, including colorectal cancer.

What other types of research exist?

Promising novel alternatives to M9140 for colorectal cancer patients include: 1) Pembrolizumab, an immune checkpoint inhibitor, which has shown efficacy in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. 2) Nivolumab, another immune checkpoint inhibitor, often used in combination with ipilimumab for MSI-H/dMMR colorectal cancer. 3) Encorafenib combined with cetuximab, targeting BRAF V600E-mutant metastatic colorectal cancer. 4) Trifluridine/tipiracil (TAS-102) combined with bevacizumab, which has shown improved outcomes in refractory metastatic colorectal cancer. These therapies are based on recent clinical trial data and are expected to be significant in 2024.

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Anti-tumor Antibody-drug Conjugate

M9140 for Colorectal Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for colorectal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy, such as fluoropyrimidine-based regimens, works by interfering with DNA replication in rapidly dividing cancer cells, leading to cell death. Targeted therapies, like cetuximab and bevacizumab, inhibit specific molecules involved in tumor growth and angiogenesis, respectively. Immunotherapy, including agents like pembrolizumab, enhances the body's immune response against cancer cells by targeting immune checkpoints. These treatments are crucial for colorectal cancer patients as they offer multiple strategies to control tumor growth, improve survival rates, and potentially reduce recurrence, especially in advanced stages of the disease.

Phase 1

Recruiting

Research Sponsored by EMD Serono Research & Development Institute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called M9140 to see if it is safe and effective for patients with advanced solid tumors. Researchers will study how the drug behaves in the body, how well patients can tolerate it, and if it shows any signs of fighting the cancer.

Who is the study for?

This trial is for adults with advanced colorectal cancer who've had no luck or bad reactions to standard treatments. They must be in good physical shape (ECOG PS < 1), and have their major organs working well. It's not for those with recent other cancers, brain metastases causing symptoms, chronic bowel inflammation, serious heart issues within the past 6 months, or certain severe digestive problems.

What is being tested?

The study tests M9140, a new drug aimed at solid tumors like colorectal cancer. Participants will also receive Bevacizumab and Capecitabine. The trial has two parts: first finding the right dose of M9140 (Part 1) and then seeing how well it works at that dose (Part 2).

What are the potential side effects?

Possible side effects include typical reactions to cancer drugs such as fatigue, nausea, diarrhea, risk of infection due to low blood counts; specific side effects related to M9140 are being studied since this is its first use in humans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Part 2D: M9140 + 5-fluorouracil + Folinic acid + BevacizumabExperimental Treatment3 Interventions

Group II: Part 2C: M9140 + Bevacizumab +/-CapecitabineExperimental Treatment3 Interventions

Group III: Part 2B: M9140Experimental Treatment1 Intervention

Group IV: Part 2A: M9140Experimental Treatment1 Intervention

Group V: Part 1: M9140Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Folinic acid

2018

Completed Phase 3

~1860

5-fluorouracil (5-FU)

2008

Completed Phase 3

~1300

Bevacizumab

2013

Completed Phase 4

~5540

Capecitabine

2013

Completed Phase 3

~4280

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy, such as fluoropyrimidine-based regimens, works by interfering with DNA replication in rapidly dividing cancer cells, leading to cell death. Targeted therapies, like cetuximab and bevacizumab, inhibit specific molecules involved in tumor growth and angiogenesis, respectively. Immunotherapy, including agents like pembrolizumab, enhances the body's immune response against cancer cells by targeting immune checkpoints. These treatments are crucial for colorectal cancer patients as they offer multiple strategies to control tumor growth, improve survival rates, and potentially reduce recurrence, especially in advanced stages of the disease.